Biological response modifiers, more commonly referred to as biologics are considered a highly effective treatment option for patients with moderate to severe psoriasis.

Biologics are made from proteins that are either similar to or the same as proteins in the body’s immune system. Biologics target and block the immune system cells responsible for inflammation in the body (such as TNF-Alpha (tumour necrosis factor-alpha), interleukin 17-A or interleukins 12 and 23.) These cells and proteins all play a major role in developing psoriasis and psoriatic arthritis. However, this activity also weakens the ability to fight infections. Thus before starting biologic therapy, people usually have standard vaccinations for flu, hepatitis A and B, pneumonia, tetanus, diptheria and other infectious diseases.

Before treatment begins, people generally have routine tests to detect liver problems, hepatitis and tuberculosis. If you have or develop a serious infection, biologic therapy must stop until you are better.

People with congestive heart failure, multiple sclerosis (MS) or similar diseases, or MS in their family cannot take biologics. These medications should be used cautiously in people with a history or family history of cancer.

Most biologics are given by injection just under the skin (subcutaneous injection) and can be administered by a nurse or by the patients themselves after proper training. Common side effects include mild skin reactions at the injection site, nausea, upper respiratory tract infection, rash and headache.

Another biologic, infliximab, is given by intravenous infusion or “drip” at a day clinic or hospital rheumatology department under medical supervision. Infusions are given at two weeks, then six weeks after the first infusion, then every eight weeks. Each infusion takes about two hours, with an observation period of about one hour or more afterward. Common side effects can include fever, rash, headache, and muscle or joint pain.

 

How they work

Biologics that are used to treat moderate to severe psoriasis in Canada are generally in categories based on how they work:

  • TNF inhibitors
  • Interleukin inhibitors

 

TNF inhibitors

These biologics block the action of tumour necrosis factor (TNF) made by the immune system. Some people with psoriasis have too much TNF in their bodies, and this overabundance of TNF can cause skin inflammation. TNF blockers can reduce the amount of TNF in the body to normal levels. Anti-TNFs are widely used in other indications such as rheumatoid arthritis or psoriatic arthritis and have a demonstrated longer history with a predictable side effect profile.

As TNF inhibitors may reduce your ability to fight off infections tell your doctor if you have any sign of an infection or if you have a history of tuberculosis (TB) or hepatitis B. Also let your doctor know if you have infections that keep coming back or if you have a condition like diabetes, which might increase your risk of infections. If you require a live vaccine, or if you are pregnant or nursing, you should discuss with your doctor whether to stop taking your medication temporarily.

Common side effects

TNF blockers may cause pain, inflammation, bleeding or swelling at the site of injection. Some may experience upper respiratory tract infections, headache, rash, nausea, abdominal pain or urinary tract infection. Fatigue, skin infection, rash, headache, injection site reaction, joint and back pain, liver function effects have also been seen.

 

Interleukin inhibitors

Interleukin inhibitors can prevent specific proteins in the body—called interleukins—from causing the body’s immune system to attack the skin and nails. The medicines work by neutralizing the activities of specific proteins which are present at increased levels in diseases such as psoriasis.

Interleukin inhibitors may affect your ability to fight off infections. Tell your doctor if you have any sign of an infection or if you have a history of tuberculosis (TB) or hepatitis B. If you require a live vaccine, or if you are pregnant or nursing, you should discuss with your doctor whether you need to stop taking your medication temporarily.

Common side effects

Common side effects include upper respiratory infections such as sinus infection and sore throat, injection site reactions, nausea, fatigue.

 

Biosimilars (or Subsequent Entry Biologics/ SEB)

Biosimilars (also referred to as a subsequent entry biologic or SEB) are biologic medications that are similar to, but not identical versions of an existing biologic (also called an innovator or reference drug). Biosimilars are only similar to their reference drug.  Biologics are large molecules that are produced by living organisms and therefore it is not possible to make an exact copy of them.

Please see Biosimilars section for more information, important considerations and our position on Biosimilars. THE DECISION TO USE A BIOSIMILAR (OR A BIOLOGIC) MUST SOLELY BE IN THE HANDS OF THE PATIENTS LIVING WITH PSORIATIC DISEASE AND THEIR PHYSICIAN.

 

For a comparison of Biologics medications see Biologics Treatments Table